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Aducanumab, a Novel Anti-Amyloid Monoclonal Antibody, for the Treatment of Alzheimer’s Disease: A Comprehensive Review
Published 2022-01-01“…Currently aducanumab is the only Food and Drug Administration (FDA) approved drug that acts to slow progression of this disease. …”
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103
Is a Consensus Case Definition for Viral Associated Lower Respiratory Tract Disease (LRTD) in Clinical Trials Possible?
Published 2024-12-01“…Here we review the key differences in criteria for case definitions, highlight strategies to best approximate compatibility between definitions, and review vaccine efficacy results among currently US Food and Drug Administration (FDA)-approved vaccines using these strategies. …”
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Cancer treatment comes to age: from one-size-fits-all to next-generation sequencing (NGS) technologies
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105
Administrative Criminal Reform in Providing Accountability for Skincare Actors Who Have Not Registered with BPOM
Published 2024-12-01“…The study aimed to analyze which problem from skincare products none approval from Indonesian Food and Drug Administration (BPOM) This is serious problem the affects public health and damages consumer trust. …”
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Mesenchymal Stem Cells as New Therapeutic Agents for the Treatment of Primary Biliary Cholangitis
Published 2017-01-01“…Ursodeoxycholic acid and obethicholic acid are the only agents approved by the US Food and Drug Administration (FDA) for the treatment of PBC. …”
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107
Iron Chelators in Treatment of Iron Overload
Published 2022-01-01“…In clinical use, deferoxamine, deferiprone, and deferasirox are the three United States Food and Drug Administration-approved iron chelators. Each of these iron chelators is well known for the treatment of iron overload in various clinical conditions. …”
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Large Pelvic Hematoma after UroLift® Procedure for Treatment of BPH with Median Lobe
Published 2022-01-01“…Since 2015, there have been 27 cases of pelvic hematoma after UroLift® reported to the United States Food and Drug Administration (FDA), and only 2 cases published in the literature. …”
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Neratinib as a Potential Therapeutic for Mutant RAS and Osimertinib-Resistant Tumours
Published 2022-09-01“…Neratinib is U.S. Food and Drug Administration (FDA)-approved as a neo-adjuvant therapy for use in HER2+ breast cancer. …”
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Shifting the paradigm of type 1 diabetes: a narrative review of disease-modifying therapies
Published 2024-11-01“…To date, only one medication, teplizumab, has been approved by the Food and Drug Administration (FDA) for the treatment of stage 2 T1D. …”
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A Standardized Approach to Quantitative Analysis of Nicotine in e-Liquids Based on Peak Purity Criteria Using High-Performance Liquid Chromatography
Published 2018-01-01“…Although the Food and Drug Administration (FDA) has recently started regulating e-cigarette products, no limits on nicotine and other ingredients in such products have been proposed. …”
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Literature Study of Formulating and Testing Physical Properties of Hand Sanitizer Preparations of Various Plant Extracts
Published 2022-03-01“…According to the US FDA (Food and Drug Administration) the advantages of hand sanitizers are that they are able to kill germs in a relatively fast time. …”
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Acknowledging and addressing real-world challenges to treating immune-related adverse events
Published 2024-07-01“…The latter is complicated by the lack of US Food and Drug Administration-approved irAE treatments that lead to insurance denials, as well as the high cost of biological immunosuppressant therapies. …”
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Complex Laparoscopic Myomectomy with Severe Adhesions Performed with Proper Preventive Measures and Power Morcellation Provides a Safe Choice in Certain Infertility Cases
Published 2016-01-01“…Two years ago, the Food and Drug Administration in the United States of America (FDA) issued the alert on power morcellation for uterine leiomyomas, addressing the risk of malignant cell spreading within the abdominal cavity (actual risk assessment from 1 in 360 to 1 in 7400 cases). …”
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FDA-approved kinase inhibitors: a promising therapeutic avenue for traumatic brain injury
Published 2024-12-01“…Nowadays, kinase inhibitors approved by the Food and Drug Administration (FDA) mainly for cancer treatment have shown potential effects in TBI. …”
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Pimobendan oral solution is bioequivalent to pimobendan chewable tablets in beagle dogs
Published 2025-01-01“…Conclusions and Clinical Importance The novel oral solution of pimobendan was found to be bioequivalent, both applying the Food and Drug Administration (FDA) supported RSABE method and based on pharmacodynamic data. …”
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Safety and effectiveness of an herbal decoction (modified Saengmaeksan) in hypertensive patients: Protocol for a real-world prospective observational study.
Published 2025-01-01“…The study's goal is to support the approval of modified Saengmaeksan as a hypertension treatment by the South Korean Food and Drug Administration and to promote the industrialization of traditional herbal medicine in managing hypertension. …”
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Second-generation anti-amyloid monoclonal antibodies for Alzheimer’s disease: current landscape and future perspectives
Published 2025-01-01“…Specifically, based on their efficacy in removing Aβ plaques from the brains of patients with AD, the U.S. Food and Drug Administration has approved three anti-amyloid MABs, aducanumab (Aduhelm®), lecanemab (Leqembi®), and donanemab (Kisunla™). …”
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Food recalls: An unnecessary and preventable factor in food waste
Published 2025-01-01“…Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA) into three classes based on the severity of health risks, with Class I being the most severe; a Class I recall is for defective products that can cause severe health effects or death (FDA, 2024, p. 7-1; UDSA Food Safety and Inspection Service [USDA FSIS], 2024-b). …”
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Investigating the Safety of Fampridine in Patients with Different Stages of Multiple Sclerosis
Published 2025-01-01“…Background: Fampridine is the only drug approved by the US Food and Drug Administration (FDA) for people with multiple sclerosis (MS) to improve their movement and has exhibited a clinically significant improvement in gait function in a subset of MS patients with Expanded Disability Status Scale (ESDSS) from 4 to 7. …”
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